Immediate-Release Oxycodone Capsules Study in Cancer Pain | NCT01675622

NCT01675622

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Oxycodone Capsules for cancer pain	Experimental		Drug: Oxycodone
Morphine tablets for cancer pain	Active Comparator		Drug: Morphine

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days	Oxycodone Capsules for cancer pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical Rating Scale (NRS)	The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.	baseline up to 5-8 days (double blind period)

Secondary Outcomes

Measure	Description	Time Frame
The Average Dose of Study Medicine Used During Double Blind Treatment Period	the average dose of study medicine used during double blind treatment period between the two treatment groups.	baseline up to 5-8 days (double blind period)
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.
Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating Scale ≥4.
Patients who can understand and are able to complete Numeric Rating Scale and Brief Pain Inventory assessment.
Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

Patients who are pregnant, or lactating.
Patients who are unable to manage their pain effectively with opioids.
Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study entry;
Patients who are receiving chemotherapy, or still under the responsive period of chemotherapy (patients who are at the interval period of chemotherapy can be enrolled into study. That is to say, patients who completed chemotherapy for more than 2 weeks can enrolled, or patients has completed chemotherapy for at least one week could be enrolled at the discretion of the investigator).
Patients who have received radio-therapy for bony metastasis, patients receiving radiotherapy within the 4 week period before study entry (patient receiving radiotherapy for area other than pain area can be enrolled) , or patients who were scheduled to receive radiotherapy for pain area during study period.
Patients are receiving or should receive anti-convulsion drugs/anti- depression drugs considered by investigator for the treatment of neuropathy pain. Patients are receiving or should receive any analgesic other than study medicine, which including NSAIDs.
Patients with other unstable disease, or with dysfunction of important organ.
Patients with an ongoing infection, abscess or fever.
Patient with serious abnormal liver/ renal function (ALT/Aspartate Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;
Paralytic or mechanical ileus;
Persistent asthma, chronic obstructive diseases, and cor pulmonary;
Intracranial neoplasms, and intracranial hypertension with central respiratory depression risk.
Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last 2 weeks;
Patients who are currently taking active treatment for epilepsy or arrhythmias.
Patients with known sensitivity or record of specific or allergic reaction to oxycodone or morphine.
Patients excluded by the contra-indications, adverse drug reaction (ADRs) and drug interactions of oxycodone or morphine as detailed in the data sheet, summary of product characteristics or investigator's brochure.
Patients with a history of drug or alcohol abuse.
Patients who participated in another clinical research study involving a new chemical entity within one month prior to study entry.
Patients whose concomitant medication is likely to be changed within the study period, with the exception of treatment for opioid side effects.
Patients who, in the opinion of the investigator, are unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.

Name	Affiliation	Role
Shiying Yu, Prof.	Wuhan TongJi Hospital	Principal Investigator

Arm/Group Information

ID	Title	Description
FG000	Oxycodone Capsules for Cancer Pain	Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2. period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.
FG001	Morphine Tablets for Cancer Pain	Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2. period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Oxycodone Capsules for Cancer Pain	Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
BG001	Morphine Tablets for Cancer Pain

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Numerical Rating Scale (NRS)

The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.

Posted

Mean

Standard Deviation

scores on a scale

baseline up to 5-8 days (double blind period)

ID	Title	Description
OG000	Oxycodone Capsules for Cancer Pain	Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
OG001	Morphine Tablets for Cancer Pain

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oxycodone Capsules for Cancer Pain	Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Respiratory and circulatory failure	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	4 patients died of respiratory/circulatory failure due to progression of the underlying disease, which were not related to the study drug determined by the investigator

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

ID	Term
D009369	Neoplasms
D000072716	Cancer Pain